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| Brand | Scintomics |
|---|---|
| Origin | Germany |
| Model | GRP 2V–6V Modular System |
| Configuration | Fully modular (base module + up to 5 valve modules + up to 4 syringe-driven distribution modules) |
| Regulatory Design Basis | Compliant with GMP, ISO 13485, and applicable IEC 61010-1 safety standards for Class II medical device manufacturing environments |
| Software Architecture | Windows-based control interface with audit trail, user access levels, and electronic signature support per FDA 21 CFR Part 11 requirements |
| Radiation Shielding | Integrated lead–tungsten composite shielding (≥15 cm Pb-equivalent for 511 keV photons) |
| Operating Environment | Designed for hot cell integration (Class C cleanroom compatible, IP54-rated modules) |
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